NEW
Font size
WorksheetsHandling Of Out Of Specification results
Total questions: 5
Worksheet time: 5mins
Here's what should you do if your sample considered OOS, except...
Make sure that an internal investigation is completed
Review all cGMP documents associated with the product
Must determine if there were any deviation from the SOP
Test until passed
These are the responsibilities of an analyst, except...
Achieving accurate laboratory results
Analyst continue the analysis when obvious errors are known
Should be aware of potential problems that could occur
An assessment of the accuracy of the results should be started immediately
Description of the testing should be written, and then approved by QA. The requirements of investigational testing should include...
The description not fully documented
The hypotesis has not been investigated
What samples will be tested
Improper test execution
As part of Phase 1 investigation, an analyst is carried out to identify any error that may have occured in the laboratory, except...
Improper hypotesis
Dilution error of standard and sample solution
Error in analysis method
Equipment malfunction
These are the general investigation principles, except...
The reason for the investigation has been clearly identified
A review is made to determine if the problem has occured previously
No impact assessment is required
Corrective / preventive actions taken are described and implemented
